NCT05141162

Brief Summary

Regardless of the type of surgical intervention, it is a negative life experience for the child and family members and is known to cause anxiety. Having a surgical incision in the child's body and the likelihood of developing conditions such as pain, organ loss or death, change in the parental role, and the hospital environment are situations that increase the stress of the parents. Hernia is the most common surgical pathology in children. Hernias are also risky in terms of complications. Parents' experiencing severe anxiety may prevent their ability to understand the child's explanations correctly, interpret events realistically, make correct decisions, participate in the care of the child, and use appropriate coping methods. Parents abandon their habitual attitudes because they feel anxiety and sadness. Their tolerance increases and, as a result, they do whatever their children want. This change in the attitudes of the parents may increase the anxiety of the child and make him feel more sick than he is. Therefore, it is very important for the child to reduce the parent's anxiety. At the pathological level, anxiety requires pharmacological and / or psychosocial intervention. The main purpose of psychosocial intervention is to understand and discover one's emotions. Some authors mention the benefits of using expressive methods. Art practices are at the top of the expressionist methods, and according to the nursing interventions classification system (NIC), art therapy is among the nursing interventions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2021

Completed
10 months until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 14, 2021

Last Update Submit

April 30, 2023

Conditions

Keywords

Knittinganxietyherniaart therapy

Outcome Measures

Primary Outcomes (10)

  • Anxiety Levels of Mothers

    Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.

    15 minutes after the start of surgery

  • Anxiety Levels of Mothers

    Anxiety Levels of Mothers will be defined with the State-Trait Anxiety Inventory.

    1 hour after the start of surgery

  • Heartbeat of mothers

    heartbeat per minutes

    15 minutes after the start of surgery

  • Heartbeat of mothers

    heartbeat per minutes

    1 hour after the start of surgery

  • Breathing rate of mothers

    breathing rate per minutes

    15 minutes after the start of surgery

  • Breathing rate of mothers

    breathing rate per minutes

    1 hour after the start of surgery

  • Blood pressure of mothers

    blood pressure in mmHg

    15 minutes after the start of surgery

  • Blood pressure of mothers

    blood pressure in mmHg

    1 hour after the start of surgery

  • Oxygen saturation of mothers

    oxygen saturation in percent

    15 minutes after the start of surgery

  • Oxygen saturation of mothers

    oxygen saturation in percent

    1 hour after the start of surgery

Study Arms (2)

case group

EXPERIMENTAL

In the first stage, an information form including socio-demographic characteristics prepared within the framework of the literature and State-Trait Anxiety Inventory will be applied to mothers before surgery. Later, the experimental group will be knitted by the researcher during the surgical operation. The necessary materials (knitting needle and thread) for the knitting attempt will be given to the participants in the experimental group by the researcher. A neutral color, white, will be used as the knitting yarn color. Knitting will start 15 minutes after the child enters the operation and will be knitted for 30-40 minutes on average. At the end of the surgery, the State-Trait Anxiety Inventory scale will be applied again to evaluate the anxiety levels of the participants in the experimental and control groups. The vital signs of the mothers will be measured at the beginning of the operation and close to the end of the operation.

Behavioral: case and control group

control group

NO INTERVENTION

An information form including socio-demographic characteristics prepared within the framework of the preoperative literature and State-Trait Anxiety Inventory will be applied to mothers. No attempt will be made to this group. At the end of the surgery, the State Trait Anxiety Inventory scale will be applied again to evaluate the anxiety levels of the participants in the experimental and control groups. The vital signs of the mothers will be measured at the beginning of the operation and near the end of the operation.

Interventions

randomized controlled experimental study

case group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsResearch evidence shows that especially mothers have a high level of anxiety during surgery.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers know how to knit,
  • Mothers' willingness to participate in the study,
  • The child has not had a previous surgical operation.
  • The mother has not had any psychological trauma or psychiatric diagnosis in the last six months.

You may not qualify if:

  • Mothers do not know how to knit,
  • Refusal of mothers to participate in research,
  • The child has had previous surgery,
  • The mother's history of any psychological trauma or psychiatric diagnosis in the last six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Universyt

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Kumar A, Das S, Chauhan S, Kiran U, Satapathy S. Perioperative Anxiety and Stress in Children Undergoing Congenital Cardiac Surgery and Their Parents: Effect of Brief Intervention-A Randomized Control Trial. J Cardiothorac Vasc Anesth. 2019 May;33(5):1244-1250. doi: 10.1053/j.jvca.2018.08.187. Epub 2018 Aug 22.

    PMID: 30243867BACKGROUND
  • Pomicino L, Maccacari E, Buchini S. Levels of anxiety in parents in the 24 hr before and after their child's surgery: A descriptive study. J Clin Nurs. 2018 Jan;27(1-2):278-287. doi: 10.1111/jocn.13895. Epub 2017 Dec 11.

    PMID: 28544343BACKGROUND
  • Brooks L, Ta KN, Townsend AF, Backman CL. "I just love it": Avid knitters describe health and well-being through occupation. Can J Occup Ther. 2019 Apr;86(2):114-124. doi: 10.1177/0008417419831401. Epub 2019 Mar 11.

    PMID: 30857405BACKGROUND
  • Pollanen S. The meaning of craft: craft makers' descriptions of craft as an occupation. Scand J Occup Ther. 2013 May;20(3):217-27. doi: 10.3109/11038128.2012.725182. Epub 2012 Sep 19.

    PMID: 22989300BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersHernia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

January 14, 2021

First Posted

December 2, 2021

Study Start

November 24, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations